Malaria Prevention Cambodia (MPC)

This study has suspended participant recruitment.
(Medication safety concern)
Sponsor:
Collaborators:
National Center for Parasitology, Entomology and Malaria Control, Cambodia
Royal Cambodian Armed Forces
United States Army Medical Materiel Development Activity
Information provided by (Responsible Party):
David Saunders, Armed Forces Research Institute of Medical Sciences, Thailand
ClinicalTrials.gov Identifier:
NCT01624337
First received: June 17, 2012
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

Trial of monthly DHA-piperaquine for malaria prevention in health volunteers.


Condition Intervention
Malaria
Drug: DHA-piperaquine
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double Blind, Placebo-controlled Clinical Trial of Monthly DHA-piperaquine for Malaria Prevention in Cambodia.

Resource links provided by NLM:


Further study details as provided by Armed Forces Research Institute of Medical Sciences, Thailand:

Primary Outcome Measures:
  • Protective efficacy [ Time Frame: 4 months ] [ Designated as safety issue: No ]

    To quantify protective efficacy for the prevention of malaria infection in a setting of mixed multidrug resistant P. falciparum and P. vivax malaria, particularly in non-immune volunteers, in two treatment groups - monthly DHA-piperaquine vs. placebo.

    Protective efficacy will be defined by reduction in the incidence of malaria between treatment and placebo groups.



Secondary Outcome Measures:
  • Cardiac safety of piperaquine as determined by QT interval prolongation [ Time Frame: 4-5 months ] [ Designated as safety issue: Yes ]
    To document the effect on the electrocardiogram (EKG), particularly the QTc interval, in patients taking repeated monthly treatment courses of DHA-piperaquine.


Estimated Enrollment: 231
Study Start Date: May 2012
Arms Assigned Interventions
Experimental: DHA-piperaquine
DHA-piperaquine monthly 2 day treatment course
Drug: DHA-piperaquine

Drug: Dihydroartemisinin piperaquine

40/320 mg tablets, 9 tablets total Arms: 2 day treatment course (4.5 tablets per day)

Other Name: Duocotexcin
Placebo Comparator: Placebo
Matching placebo control
Drug: placebo

Detailed Description:

This is a two arm, randomized, double-blind, placebo controlled cohort study to determine the protective efficacy of a monthly 2 day treatment course of Dihydroartemisinin-Piperaquine (DP) in adult volunteers in malaria endemic areas of Cambodia.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Volunteer 18-65 years of age
  2. Able to give informed consent
  3. Likely to reside in malaria endemic area for the duration of the study
  4. Available for follow-up for anticipated study duration, and agrees to participate for the duration of the study
  5. Agrees not to seek outside medical care for febrile illness, except in emergency situations, unless referred by study team
  6. Authorized by local commander to participate in the study if on active duty

Exclusion Criteria:

  1. Known allergy or other contraindication to DHA, piperaquine treatment, and/or primaquine treatment
  2. Significant acute comorbidity requiring urgent medical intervention
  3. Positive malaria blood smear.
  4. Treatment with an antimalarial drug in the past 30 days.
  5. Pregnant or lactating female or a female of childbearing age who does not agree to use a highly effective method of birth control during the study
  6. Significantly abnormal EKG including a QTcF interval greater than 450ms at baseline (or 470ms for females) using Fridericia's correction
  7. Regular current use of known QTc prolonging medications
  8. History of sudden cardiac death in an immediate family member, or personal history of known symptomatic coronary artery disease or arrhythmias
  9. Judged by the investigator to be otherwise unsuitable for study participation or non-compliant with study requirements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624337

Locations
Cambodia
Anlong Veng Referral Hospital
Anlong Veng, Oddar Meancheay, Cambodia
Sponsors and Collaborators
Armed Forces Research Institute of Medical Sciences, Thailand
National Center for Parasitology, Entomology and Malaria Control, Cambodia
Royal Cambodian Armed Forces
United States Army Medical Materiel Development Activity
Investigators
Principal Investigator: DAVID SAUNDERS, MD, MPH Armed Forces Research Institute of Medical Sciences, Thailand
Principal Investigator: Chanthap Lon, MD Armed Forces Research Institute of Medical Sciences, Thailand
  More Information

No publications provided

Responsible Party: David Saunders, Chief, Department of Immunology and Medicine, Armed Forces Research Institute of Medical Sciences, Thailand
ClinicalTrials.gov Identifier: NCT01624337     History of Changes
Other Study ID Numbers: WRAIR # 1849, A-17057
Study First Received: June 17, 2012
Last Updated: June 19, 2012
Health Authority: Cambodia: Ministry of Health

Keywords provided by Armed Forces Research Institute of Medical Sciences, Thailand:
Plasmodium falciparum
Plasmodium vivax

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Piperaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014